MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX-XRY59801

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

Weight - (b)(6).Implanted date: device was not implanted.Explanted date: device was not explanted.510k - k130520.The actual device was not returned to the manufacturing facility for evaluation.However, a retention sample for which the fiber of the same fiber lot number as that of the actual sample had been used was evaluated.The retention sample was tested for its gas transfer performance.Bovine blood arranged to (hb12.0 g/dl and temp.At 37oc) was circulated in the oxygenator module under the following conditions: at v/q=1, fio2=100% and the flow rate of 5l/min.And 3l/min.Result: o2 transfer: at5l/min.= 314ml/min.At 3l/min.= 210ml/min.Co2 removal: at 5l/min.= 255ml/min.At 3l/min.= 173ml/min.No anomalies were revealed in the gas transfer performance of the retention sample, with the obtained values meeting the manufacturer specifications.A review of the device history record of the product code/lot# combination was conducted with no findings.Ifu states: upon patient rewarming, adjust o2 concentration, gas flow rate and blood flow rate by increasing them as needed based on an increase in patient's metabolism.Failure to adjust the gas supply and the blood flow rate appropriately may cause insufficient o2 supply needed or the amount of the patient's gaseous metabolism.Measure blood gases and make necessary adjustments as follows.Control pao2 by changing concentration of oxygen in ventilating gas using gas blender.To decrease pao2, decrease fio2.To increase pao2, increase fio2.There is no evidence that this event was related to a device defect or malfunction.The investigation results verified the retention sample was of the normal product.However, with no return of the actual sample, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported the involved capiox device was used, and that during the procedure, when the user decreased fio2 at the blood flow rate of 4.5l/min., the pao2 went down much lower than he had expected.There was no blood loss, and the patient was no harmed.The procedure outcome was reported to be unknown.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: mark vornheder ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 8340573
• MDR Text Key: 139474876
• Report Number: 9681834-2019-00007
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: CX-XRY59801
• Device Lot Number: 181108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 70